Results from a two-year comparative effectiveness randomized clinical trial are summarized in this news release from the National Institutes of Health (NIH). The trial compared aflibercept (marketed as Eylea), bevacizumab (Avastin) and ranibizumab (Lucentis) in the treatment of 660 people with vision loss caused by diabetic macular edema (DME). The trial found that all three commonly prescribed drugs were effective in treating DME but that among patients with 20/50 vision or worse, Eylea led to better outcomes than Avastin. In patients with 20/32 or 20/40 vision at the start of treatment, all three drugs were equally effective. Fewer of the patients receiving Eylea needed corrective laser treatment to meet a visual acuity of 20/40, which is necessary to pass a driving exam (41% versus 64% for those getting Avastin and 52% who received Lucentis).
The release is an exemplary presentation of an important study. It provides detailed cost information, presents benefits in terms that are meaningful to readers, and pays considerable attention to the potential harms of these treatments. The only area that we found Not Satisfactory was the discussion of novelty: we felt that the release could have done even more to explain just how uncommon this type of study is and why it’s newsworthy.
Patients with diabetes are at risk of developing DME, a consequence of diabetic retinopathy. It causes swelling in an area of the retina called the macula due to fluid build-up. Diabetic retinopathy is responsible for an estimated 12,000 to 24,000 new cases of blindness in the United States each year.
The reason this particular trial matters is that it compares three existing drug treatments for DME which vary significantly in cost. The difference in cost for these medicines has been a huge issue in ophthalmology. Comparative effectiveness trials are desirable and necessary in a system that seeks to contain health care costs.
The release states that based on Medicare allowable charges, each injection of Eylea costs $1,850, Lucentis is $1,200 per injection and Avastin is $60 per injection. Patients received nine monthly injections, on average. This is good detail, although total costs of all treatments (medication plus laser) would have been even more helpful.
The release states the general benefits over time for each group assigned to one of three drugs and gives some specifics about the improvements seen.
Among participants with 20/50 or worse vision at the trial’s start, visual acuity on average improved substantially in all three groups. At two years, Eylea participants were able to read about 3.5 additional lines on an eye chart; Lucentis participants were able to read about three additional lines, and Avastin participants improved about 2.5 lines.
The release also does a pretty good job of quantifying how many people in each group needed laser surgery.
By two years, 41 percent of participants in the Eylea group received laser treatment to treat their macular edema, compared with 64 percent of participants in the Avastin group and 52 percent in the Lucentis group.
The release notes that “The risk of heart attack, stroke, or death from a cardiovascular condition or an unknown cause by the end of the trial was higher among patients in the Lucentis group. Twelve percent of Lucentis participants had at least one event, compared with five percent of the participants in the Eylea group and eight percent of the participants in the Avantis group.” This is useful information. The release also points out that more study is needed to determine if these treatments affect the rate of heart problems or if this observation was due to chance.
The release is very thorough in describing the format of the trial, the volunteer population and how they were selected, how long the trial lasted, and the different drug formulations. One significant concern is that the trial was not blinded, and this could introduce bias as there are some strong opinions among ophthalmologists on this issue. The release did not comment on this. In addition, the time trends could have been discussed more, as the differences narrowed over time and might have continued to decrease with additional follow-up. But the discussion of evidence overall is Satisfactory.
The release does not engage in disease mongering.
The release clearly spells out that the trial was funded by the National Eye Institute, part of the National Institutes of Health. It further states that two drug companies provided their drugs for the trial.
Corrective laser surgery is named as the alternative therapy to drugs.
The release notes that all three drugs compared are available and in use. It could have noted that payers may not cover them all.
The release missed an opportunity to explain why this kind of research is new and important. Without studies that compare the effectiveness of existing treatments, doctors and patients have incomplete information about which treatments work best and which ones deliver the most value. Such studies are uncommon but much needed.
No unjustifiable language here.
Systematic, Criteria-Driven
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